Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma

Part of paid clinical trials in Fort Lauderdale, Florida.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00001337
Phase
PHASE2
Status
Completed

Conditions

  • Anaplastic Large-Cell Lymphoma
  • Burkitt Lymphoma
  • Diffuse Large B-Cell Lymphoma (DLBCL)
  • Gray Zone Lymphoma
  • Primary Mediastinal Large B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Etoposide — DRUG
    Etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Combination chemotherapy given with Rituximab, Etoposide, VP-16; Prednisone, Cyclophosphamide, Vincristine, and Doxorubicin (EPOCH-R) intravenous (IV) every 3 weeks for 6 cycles.
  • Rituximab — BIOLOGICAL
    Rituximab given on Day 1 of combination chemotherapy (EPOCH-R) every 3 weeks for 6 cycles. Combination chemotherapy given with Rituximab, Etoposide, VP-16; Prednisone, Cyclophosphamide, Vincristine, and Doxorubicin (EPOCH-R) intravenous (IV) every 3 weeks for 6 cycles.
  • Prednisone — DRUG
    Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days. Combination chemotherapy given with Rituximab, Etoposide, VP-16; Prednisone, Cyclophosphamide, Vincristine, and Doxorubicin (EPOCH-R) intravenous (IV) every 3 weeks for 6 cycles.
  • Cyclophosphamide — DRUG
    Cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Combination chemotherapy given with Rituximab, Etoposide, VP-16; Prednisone, Cyclophosphamide, Vincristine, and Doxorubicin (EPOCH-R) intravenous (IV) every 3 weeks for 6 cycles.
  • Vincristine — DRUG
    Vincristine 0.4mg/m\^2/day. Combination chemotherapy given with Rituximab, Etoposide, VP-16; Prednisone, Cyclophosphamide, Vincristine, and Doxorubicin (EPOCH-R) intravenous (IV) every 3 weeks for 6 cycles.
  • Doxorubicin — DRUG
    Doxorubicin 10mg/m\^2/day. Combination chemotherapy given with Rituximab, Etoposide, VP-16; Prednisone, Cyclophosphamide, Vincristine, and Doxorubicin (EPOCH-R) intravenous (IV) every 3 weeks for 6 cycles.
  • MRI — DIAGNOSTIC_TEST
    Baseline and/or on completion of therapy.
  • CT — DIAGNOSTIC_TEST
    Baseline and/or on completion of therapy.
  • Biopsy — PROCEDURE
    Baseline and/or on completion of therapy.
  • PET scan — DIAGNOSTIC_TEST
    As clinically indicated.
  • Laparotomy — PROCEDURE
    As clinically indicated.
  • Ondansetron — OTHER
    Nausea and/or vomiting.
  • Prochlorperazine — OTHER
    Nausea and/or vomiting.
  • Omeprazole — OTHER
    Gastroesophageal reflux disease (GERD).
  • Docusate Sodium + Sennosides — OTHER
    Constipation.
  • Lactulose — OTHER
    Constipation

Study Details

5-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation. Etoposide phosphate, prednisone, vincristine sulfate (Oncovin), cyclophosphamide, and doxorubicin hydrochloride (hydroxydaunorubicin)(EPOCH): Etoposide, VP-16, NSC-141540; Prednisone, PRED, NSC-10023; Vincristine, VCR, NSC-67574; Cyclophosphamide, CTX, NSC-26271; Doxorubicin, DOX, NSC-123127; with Granulocyte Colony-Stimulating Factor (Amgen), Granulocyte colony-stimulating factor (G-CSF), NSC-614629.

Key Dates

Start date
May 8, 1993
Status verified
Jun 2025
Primary completion
May 24, 2024
Completion
May 24, 2024

Study Design

Enrollment
348 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab)
    Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m\^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
  • Experimental: EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide)
    Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.

Primary Outcome Measure

Overall Response (Complete Response + Partial Response) [ Time Frame: Time frame was from beginning of therapy until the end of therapy, an average of 6 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Holy Cross Hospital, Fort LauderdaleFort LauderdaleFlorida33308-
University of Maryland, BaltimoreBaltimoreMaryland21201-1595-
National Institutes of Health Clinical CenterBethesdaMaryland20892-
Brigham and Women's HospitalBostonMassachusetts02115-
St. Luke's Roosevelt HospitalNew YorkNew York10025-

Find similar trials in Fort Lauderdale, FL

By research site
Holy Cross Hospital, Fort Lauderdale· Fort Lauderdale, FLUniversity of Maryland, Baltimore· Baltimore, MDNational Institutes of Health Clinical Center· Bethesda, MDBrigham and Women's Hospital· Boston, MASt. Luke's Roosevelt Hospital· New York, NY

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